Description
Tebipenem pivoxil is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection). This medicine belongs to the group of medicines known as beta-lactams. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tebipenem pivoxil in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tebipenem pivoxil in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adefovir Dipivoxil
- Cabotegravir
- Carprofen
- Cefditoren Pivoxil
- Gemfibrozil
- Ivosidenib
- Nitisinone
- Pivmecillinam
- Probenecid
- Teriflunomide
- Vadadustat
- Valproic Acid
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to beta-lactams, carbapenems, penicillins, or cephalosporins—Use may increase the risk for an allergic reaction to reoccur.
- Allergy to beta-lactams or
- Carnitine deficiency—Should not be used in patients with these conditions.
- Brain lesions or
- Kidney problems or
- Seizures, history of—Use with caution. May increase the risk for seizures.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. You may take this medicine with or without food.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For complicated urinary tract infections:
- Adults—600 milligrams (mg) taken every 6 hours for 7 to 10 days.
- Children—Use and dose must be determined by your doctor.
- For complicated urinary tract infections:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
Some patients may develop tremors or seizures while receiving this medicine. If you already have a history of seizures and you are taking medicine for seizures, you should continue unless otherwise directed by your doctor. Tell your doctor if you are taking divalproex sodium (Depakote®) or valproic acid (Depakene®).
This medicine may cause carnitine deficiency. Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, muscle pain, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.
Tebipenem pivoxil may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Before you have any medical tests, tell the provider that you are taking this medicine. The results of some tests (eg, newborn screening test) may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Diarrhea
Less common
- Dark urine
- fever
- general tiredness and weakness
- light-colored stools
- nausea and vomiting
- severe abdominal or stomach cramps and pain
- stomach tenderness
- upper right abdominal or stomach pain
- watery and severe diarrhea, which may also be bloody
- yellow eyes and skin
Rare
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- itching of the vagina or genitals
- lower back or side pain
- sore mouth or tongue
- thick, white vaginal discharge with mild or no odor
- white patches in the mouth or on the tongue
Incidence not known
- Anxiety
- blurred vision
- chest tightness
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- cough
- depression
- difficulty swallowing
- dizziness
- fast heartbeat
- headache
- hives, itching, skin rash
- increased hunger
- nervousness
- nightmares
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Rare
- Acid or sour stomach
- belching
- heartburn
- indigestion
- stomach discomfort or upset
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80011891
